目的:建立激光衍射法用于测定吸入用布地奈德混悬液的粒度分布。方法: 采用Mastersizer 3000 激光粒度分析仪和Hydro SV 型湿法进样器,样品超声混匀后立即注入样品池,折射率为1.592,吸收率为0.01,分散介质为0.5%吐温-80的布地奈德饱和溶液,其折射率为1.33,搅拌速率为1 000 r·min-1,遮光度为6%~12%。结果: 方法学精密度考察结果D50的RSD小于2.0%,D10和D90的RSD均小于5.0%;3批吸入用布地奈德混悬液粒度分布的D90均小于5 μm。结论: 该方法操作简便,准确度高,重复性好,适用于吸入用布地奈德混悬液的粒度分布测定。
Abstract
Objective: To establish a laser diffraction method for the determination of particle size distribution of budesonide suspension for inhalation. Methods: The Master sizer 3000 laser size analyzer with the Hydro SV wet sampler was used. The sample solution should be immediately measured after ultrasonication. The measurement conditions were as follows:refractive index of budesonide was 1.592, absorbency of budesonide was 0.01, dispersing medium was saturated solution of budesonide containing 0.5% Tween 80 with refractive index of 1.33, stirring rate was 1 000 r·min-1,and laser obscurations were 6%-12%. Results: RSD of D50 was lower than 2%, RSDs of D10 and D90 were both lower than 5%.The particle size distribution D90 values of 3 batches of budesonide suspension for inhalation were less than 5 μm. Conclusion: The method is simple, accurate and producible, which is suitable for the particle size detection of budesonide suspension for inhalation.
关键词
布地奈德 /
混悬液 /
粒度分布 /
激光衍射法 /
湿法测定
{{custom_keyword}} /
Key words
budesonide /
suspension /
laser diffraction method /
wet determination /
particle size distribution
{{custom_keyword}} /
中图分类号：
R 917
{{custom_clc.code}}
({{custom_clc.text}})
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] 杨珏,李羚,陆燕红,等.吸入用布地奈德混悬液在某儿童医院门急诊使用情况[J]. 医药导报, 2019,38(12):1656
YANG J, LI L, LU YH, et al. Usage of inhaled budesonide suspension in a pediatric hospital’s outpatient and emergency department[J]. Her Med, 2019, 38(12): 1656
[2] 陶婉君,江永贤,李莉,等.儿科住院患者吸入用布地奈德混悬液的使用分析[J]. 儿科药学杂志, 2021,27(5): 43
TAO WJ, JIANG YX, LI L, et al. Analysis of the use of budesonide inhalation suspension in hospitalized pediatric patients[J]. J Pediatr Pharm, 2021, 27(5): 43
[3] 王宝云,杨嵌,王世宇, 等.吸入用布地奈德混悬液在某院儿科的应用情况分析[J]. 中药与临床, 2017, 8(2):61
WANG BY, YANG Q, WANG SY, et al. Analysis of the application of nebulized suspension of budesonide in the pediatric department of a hospital[J]. Pharm Clin Chin Mater Med, 2017, 8(2): 61
[4] 周露露.我院儿科门诊雾化吸入治疗药物使用情况分析[J]. 中医药管理杂志, 2021, 29(10): 109
ZHOU LL. Analysis of the use of nebulized inhalation treatment drugs in the pediatric outpatient department of our hospital[J]. J Tradit Chin Med Manage, 2021, 29(10): 109
[5] ICH.ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances[EB/OL]. (1999-10-29) [2024-7-29]. https://www.cde.org.cn/ichWeb/guideIch/downloadAtt/1/83637becdf4e0d2c53168d67aa985e10
[6] 中华人民共和国药典2020 年版. 四部[S]. 2020:12,145
ChP 2020. Vol Ⅳ[J]. 2020: 12,145
[7] 陈祝康,陈桂良,李慧义. 药物及其制剂粒度测定法探讨[J]. 中国药品标准,2012,13(6):405
CHEN ZK, CHEN GL, LI HY. Discussion about particle size analysis for drug and pharmaceuticals[J]. Drug Stand China, 2012, 13(6):405
[8] 丁怡,章娟. 激光粒度散射法测定曲安奈德注射液粒度[J]. 药物分析杂志,2017,37(11): 2038
DING Y, ZHANG J. Determination of particle size of triamcinolone acetonide injection by laser scattering analyzer[J]. Chin J Pharm Anal, 2017, 37(11): 2038
[9] 谷广志,王也牧,刘蔚,等. 依非韦伦原料药粒度的激光散射法测定[J]. 中国医药工业杂志,2016,47(1):68
GU GZ, WANG YM, LIU W, et al. Determination of efavirenz particle size by laser light scattering method[J]. Chin J Pharm, 2016, 47(1):68
[10] 王越,吴松,薛丹,等.激光衍射法测定盐酸溴己新粒度分布的方法学研究[J]. 药物分析杂志,2021,41(8):1448
WANG Y,WU S,XUE D, et al. Methodological study of particle size distribution of bromhexine hydrochloride by laser diffraction method[J]. Chin J Pharm Anal,2021,41(8):1448
[11] United Nations Economic Commission for Europe. Globally Harmonized System of Classification and Labelling of Chemicals(GHS) [EB/OL]. New York and Geneva, 2023 [2024-07-29]. https://unece. org/sites/default/files/2023-09/GHS%20Rev 10c_0.pdf
[12] 中华人民共和国工业和信息化部.中国实施GHS手册[EB/OL]. (2013-05-31) [2024-07-29]. https://www. miit. gov. cn/cms_files/filemanager/oldfile/miit/n1146285/n1146352/n3054355/n3057569/n3057572/c3567667/part/3567668. pdf
Ministry of Industry and Information Technology of the People’s Republic of China. Manual of GHS Implementation in China[EB/OL]. (2013-05-31) [2024-07-29]. http://www. miit. gov. cn/cms_files/filemanager/oldfile/miit/n1146285/n1146352/n3054 355/n3057569/n3057572/c3567667/part/3567668. pdf
[13] 郭彬,郝刚,钱啸,等. 利伐沙班粒度分布的激光散射测定方法的建立和验证[J]. 药物分析杂志,2021,41(9):1649
GUO B, HAO G, QIAN X, et al. Establishment and validation of particle size distribution determination method of rivaroxaban by laser light scattering[J]. Chin J Pharm Anal, 2021, 41(9):1649
[14] 高旋,陈晓萍,范琳琳,等. 激光散射法测定氟米龙滴眼液的粒度分布[J]. 药物分析杂志,2022,42(10):1815
GAO X, CHEN XP, FAN LL, et al. Determination of particle size distribution of fluorometholone eye drops by laser light scattering method[J]. Chin J Pharm Anal, 2022, 42(10):1815
[15] 阮昊, 徐东海, 陈悦,等. 激光衍射法测定对乙酰氨基酚粒度分布的方法研究[J]. 中国现代应用药学, 2023, 40(2): 213
RUAN H, XU DH, CHEN Y. Methodological study on particle size distribution of paracetamol by laser particle analyzer[J]. Chin J Mod Appl Pharm, 2023, 40(2): 213
[16] GB/T 19077.1—2008粒度分析. 激光衍射法. 第1部分:通则[S]. 2008
GB/T 19077.1—2008 Particle Size Analysis-Laser Diffraction Methods—Part 1: General Principles[S]. 2008
[17] GB/T 20099—2006样品制备. 粉末在液体中的分散方法[S]. 2006
GB/T 20099—2006 Sample Preparation-Dispersing Procedures for Powders in Liquids[S]. 2006
[18] 郑敏侠,辛芳,刘晓峰. Mastersizer 2000型激光粒度仪技术参数对粒度分布的影响[J]. 中国粉体技术,2013,19(1):76
ZHENG MX, XIN F, LIU XF. Influence of Mastersizer 2000 type laserparticle analyzer technical parameterson particle size distribution[J]. China Powder Sci Technol, 2013, 19(1):76
[19] International Organization for Standardization. ISO13320. 2020: Particle Size Analysis—Laser Diffraction Methods[S]. 2020
[20] 刘丹杏,吴小飞,张歆,等. 采用激光衍射或散射技术测定原料药粒度及粒度分布的几点考虑[J]. 中国新药杂志,2022,31(17):1689
LIU DX, WU XF, ZHANG X, et al. Some considerations on the application of laser diffraction or scattering method in the measurment of the particle size and distribution of API[J]. Chin J New Drugs, 2022, 31(17):1689
{{custom_fnGroup.title_cn}}
脚注
{{custom_fn.content}}
基金
* 国家药典委员会 国家药品标准制修订研究课题(2023Y05)
{{custom_fund}}
PDF(2405 KB)
